Principal Engineer, Digital Regulatory Assurance (Life Sciences)

Required

• Strong experience in process optimization, AI enabled solutioning, audit-readiness, CAPAs and using/supporting DevOps tools and pipeline technologies.
• Experience supporting regulatory audits/inspections and implementing quality monitoring solutions.
• Project management, analytical, and documentation skills; ability to create knowledge materials and coach diverse audiences.
• Knowledge of Computer Software Assurance (CSA), digital transformation in quality, and contemporary validation practices.
• Expert knowledge of GxP regulations required.

• Provide quality and regulatory oversight for GxP-relevant applications, infrastructure platforms, and technology solutions throughout the Software Lifecycle (SLC), ensuring compliance with regulatory requirements, company standards, and quality expectations.
• Act as a trusted advisor on SLC, Computer Software Assurance (CSA), validation, infrastructure qualification, risk management, and regulatory compliance within a regulated life sciences environment.
• Lead compliance monitoring activities across assigned portfolios, including periodic reviews, audit trail reviews, validation health assessments, quality metrics, and overall lifecycle health reporting.
• Partner with business and technology teams to ensure quality, compliance, and validation requirements are built into the design, implementation, deployment, and ongoing support of technology solutions.
• Provide guidance on validation strategies, risk assessments, regulatory characterizations, deviations, CAPAs, audit observations, and other quality-related decisions.
• Lead audit and inspection readiness efforts, including preparation activities, evidence reviews, stakeholder coaching, audit support, and remediation planning.
• Drive CAPA and audit action management activities by promoting effective root cause analysis, sustainable corrective actions, timely implementation, and verification of effectiveness.
• Stay current on evolving regulatory requirements, industry trends, and emerging quality practices, and translate them into practical improvements for lifecycle processes and compliance programs.
• Serve as the primary SQA point of contact for digital process improvement initiatives, helping identify opportunities for standardization, automation, simplification, and AI enablement.
• Manage a pipeline of automation and AI opportunities, working with stakeholders and technical teams to prioritize, implement, and drive adoption of solutions that improve quality and compliance outcomes.
• Develop and maintain quality dashboards, compliance scorecards, key risk indicators, and executive reporting to provide visibility into compliance health, operational performance, and emerging risks.
• Facilitate governance reviews and cross-functional discussions to drive accountability, resolve compliance concerns, and support consistent application of quality and regulatory expectations.
• Coach and mentor practitioners and project teams on lifecycle execution, CSA principles, validation expectations, inspection readiness, and quality risk management.
• Represent SQA in governance forums, audits, inspections, and strategic initiatives, communicating risks, trends, and recommendations to business stakeholders and leadership.
• Lead continuous improvement efforts that strengthen quality processes, enhance compliance monitoring, and support AbbVie's digital quality transformation.